COVID-19 Vaccines: Information Updates

 

Latest Updates

Comirnaty COVID-19 Vaccine (Pfizer/BioNTech)
Safety Update (EMA 13 April 2022): No updates to the product information currently recommended.
NOTE: About 598 million doses of Comirnaty in adults and 26.7 million doses of Comirnaty in children and adolescents (below 18 years of age) were administered in the EU/EEA from authorisation to 03 April 2022. [ECDC data from EU Member States as well as countries for the EAA (Norwary, Iceland, Liechtenstein)].
 
 Spikevax COVID-19 Vaccine (previously Moderna COVID-19 Vaccine) (Moderna)
Safety Update (EMA 13 April 2022): No updates to the product information currently recommended.
NOTE: About 153 million doses of Spikevax in adults and 1.9 million doses of Spikevax in children and adolescents (below 18 years of age) were administered in the EU/EEA from authorisation to 03 April 2022. [ECDC data from EU Member States as well as countries for the EAA (Norwary, Iceland, Liechtenstein)].
 
 COVID-19 Vaccine Janssen (Janssen-Cilag/Johnson & Johnson)
Safety Update (EMA 13 April 2022): No updates to the product information currently recommended.
NOTE: About 19.3 million doses of COVID-19 Vaccine Janssen were administered to adults in the EU/EEA from authorisation to 03 April 2022. [ECDC data from EU Member States as well as countries for the EAA (Norwary, Iceland, Liechtenstein)].
 
Nuvaxovid COVID-19 Vaccine (Novavax)
Safety Update (EMA 13 April 2022): No updates to the product information currently recommended.
NOTE: About 149,000 doses of Nuvaxovid were administered to adults in the EU/EEA from authorisation to 03 April 2022. [ECDC data from EU Member States as well as countries for the EAA (Norwary, Iceland, Liechtenstein)].
 
Vaxzevria COVID-19 Vaccine (AstraZeneca)
Safety Update (EMA 13 April 2022): No updates to the product information currently recommended.
NOTE: About 69 million doses of Vaxzevria were administered to adults in the EU/EEA from authorisation to 03 April 2022. [ECDC data from EU Member States as well as countries for the EAA (Norwary, Iceland, Liechtenstein)].
 

Latest Safety Assessments

  •  Auto-immune hepatitis (AIH): No evidence for a causal relationship with Comirnaty or Spikevax. An assessment of whether vaccination with Comirnaty or Spikevax can cause auto-immune hepatitis (AIH) has been completed. EMA-PRAC has concluded that the currently available evidence does not support a causal association between the vaccines and this condition.
  • Corneal graft rejection (CGR): Assessment started for Comirnaty, Spikevax and Vaxzevria. EMA-PRAC started an assessment of corneal graft rejection (CGR) to establish whether it may be a side effect of COVID-19 vaccines (Comirnaty, Spikevax and Vaxzevria). CGR occurs when the body’s immune system mistakenly attacks the donor cornea (the transparent layer in front of the eye) that has replaced a damaged or diseased one. The assessment follows a very small number of cases of CGR reported after vaccination with Comirnaty, Spikevax and Vaxzevria in the medical literature and EudraVigilance. Reported cases concern suspected side effects, i.e. medical events that have been observed after vaccination, but which are not necessarily related to or caused by the vaccine.

All Updates

Comirnaty COVID-19 Vaccine (Pfizer/BioNTech)

Safety Update (EMA 13 April 2022): No updates to the product information currently recommended.
Safety Update (EMA 17 March 2022): An assessment of whether vaccination with Comirnaty can cause capillary leak syndrome (CLS) has been completed. The EMA Pharmacovigilance Risk Assessment Committee (PRAC) has concluded that there are currently insufficient data to support an update of the product information.
Safety Update (EMA 17 February 2022): The product information of the mRNA vaccines will be updated to reflect the accumulating evidence that they can be used during pregnancy and breastfeeding. PRAC started a further assessment of menstrual disorders following use of mRNA vaccines with a focus on heavy menstrual bleeding and the absence of menstruation (amenorrhoea).
Safety Update (EMA 20 January 2022): An assessment of whether vaccination can cause capillary leak syndrome (leakage of fluid from blood vessels) is ongoing.
Safety Update (EMA 09 December 2021): The overall frequency of the side effects myocarditis and pericarditis has been determined to be very rare. The risk has been confirmed to be highest in younger males; estimates of the risk will be included in the product information for Comirnaty.
Safety Update (EMA 11 November 2021): There are no updates to the product information. Further assessment of myocarditis and pericarditis is ongoing. There is currently insufficient evidence of a possible link between Comirnaty and very rare cases of multisystem inflammatory syndrome (MIS).
Safety Update (EMA 06 October 2021): Erythema multiforme (red spots/patches on the skin) and unusual or decreased feeling in the skin will be added to the product information as side effects.
Safety Update (EMA 08 September 2021): No further updates to the product information are currently recommended.
Safety Update (EMA 11 August 2021): No further updates to the product information are currently recommended.
Safety Update (EMA 14 July 2021): Inflammation of the heart muscle (myocarditis) or membrane (pericarditis) may occur in a small number of people after vaccination with Comirnaty. The product information will be updated. Comirnaty is effective in preventing COVID-19.
Safety Update (EMA 18 June 2021): Reports of inflammation of the heart muscle (myocarditis) and membrane (pericarditis) in a small number of people after vaccination continue to be assessed under an accelerated timetable. There are no updates to the product information. Comirnaty is effective in preventing COVID-19. 
More Flexible Storage Conditions (EMA 17 May 2021): The EMA human medicines committee (CHMP) has recommended a change to the approved storage conditions that will facilitate the handling of the vaccine in vaccination centres across the European Union (EU). The changes described will be included in the publicly available information on and will be implemented by the MAH in updated product labelling. Users are reminded to always refer to the label and package leaflet of the supplied product for the correct storage information. This change extends the approved storage period of the unopened thawed vial at 2-8°C (i.e. in a normal fridge after taking out of deep-freeze conditions) from five days to one month (31 days). The change was approved following assessment of additional stability study data submitted to EMA by the marketing authorisation holder (MAH). Increased flexibility in the storage and handling of the vaccine is expected to have a significant impact on planning and logistics of the vaccine roll-out in EU Member States. 
Safety Update (EMA 11 May 2021): Swelling of the face in people who have had a dermal filler injection will be added to the product information of Comirnaty as a side effect. Case reports of inflammation of the heart muscle and membrane will be further assessed.
Adolescent Indication (EMA 02 May 2021): Indication extended to include adolescents from age 12 years.
Safety Update (EMA 14 April 2021): Specific allergic skin reactions will be added to the product information.
Safety Update (EMA 29 March 2021): Swelling of the vaccinated limb usually recovers by itself.
Safety Update (EMA 04 March 2021): Diarrhoea and vomiting after vaccination have been identified as new side effects.
Safety Update (EMA 28 January 2021): Reports of suspected severe allergic reaction have not identified new aspects regarding the nature of this known side effect. No specific safety concern has been identified for vaccine use in frail elderly individuals.

 Spikevax COVID-19 Vaccine (previously Moderna COVID-19 Vaccine) (Moderna)

Safety Update (EMA 13 April 2022): No updates to the product information currently recommended.
Safety Update (EMA 17 March 2022): The EMA Pharmacovigilance Risk Assessment Committee (PRAC) recommends updating the product information with a warning to reflect the potential of flare-ups of capillary leak syndrome (leakage of fluid from blood vessels) following vaccination with Spikevax, in patients who have a medical history of this extremely rare condition.
Safety Update (EMA 17 February 2022): The product information of the mRNA vaccines will be updated to reflect the accumulating evidence that they can be used during pregnancy and breastfeeding. PRAC started a further assessment of menstrual disorders following use of mRNA vaccines with a focus on heavy menstrual bleeding and the absence of menstruation (amenorrhoea).
Safety Update (EMA 20 January 2022): The product information will be updated to include paraesthesia (unusual feeling in the skin) as a rare side effect.
Safety Update (EMA 09 December 2021): The overall frequency of the side effects myocarditis and pericarditis has been determined to be very rare. The risk has been confirmed to be highest in younger males; estimates of the risk will be included in the product information for Spikevax.
Safety Update (EMA 11 November 2021): There are no updates to the product information. Further assessment of myocarditis and pericarditis is ongoing. There is currently insufficient evidence of a possible link between Spikevax and very rare cases of multisystem inflammatory syndrome (MIS).
Safety Update (EMA 06 October 2021): Erythema multiforme (red spots/patches on the skin) will be added to the product information as a side effect.
Safety Update (EMA 08 September 2021): No further updates to the product information are currently recommended.
Safety Update (EMA 11 August 2021): No further updates to the product information are currently recommended.
Safety Update (EMA 14 July 2021): Inflammation of the heart muscle (myocarditis) or membrane (pericarditis) may occur in a small number of people after vaccination with Spikevax. The product information will be updated. Spikevax is effective in preventing COVID-19.
Safety Update (EMA 18 June 2021): Reports of inflammation of the heart muscle (myocarditis) and membrane (pericarditis) in a small number of people after vaccination continue to be assessed under an accelerated timetable. There are no updates to the product information. Spikevax (previously Moderna COVID-19 Vaccine) is effective in preventing COVID-19.
Safety Update (EMA 11 May 2021): Diarrhoea and delayed injection site reactions will be added as side effects to the product information. Case reports of inflammation of the heart muscle and membrane will be further assessed.
Safety Update (EMA 05 February 2021): This update presents the assessment of an investigation of reports of suspected severe allergic reaction coming from a single vaccination site in the United States. The assessment of these reports has not identified new aspects regarding the nature of this known side effect.
 

COVID-19 Vaccine Janssen (Janssen-Cilag/Johnson & Johnson)

Safety Update (EMA 13 April 2022): No updates to the product information currently recommended.
Safety Update (EMA 17 March 2022): The EMA Pharmacovigilance Risk Assessment Committee (PRAC) recommends updating the product information to include cutaneous small vessel vasculitis (inflammation of blood vessels in the skin which may result in a rash, pointed or flat, red spots under the skin’s surface and bruising) should be added to the product information of COVID-19 Vaccine Janssen as a possible side effect of unknown frequency. Small vessel vasculitis can be caused by viral or bacterial infections as well as by medicines and vaccines. Generally, manifestations of the disease spontaneously resolve over time with appropriate supportive care.
Safety Update (EMA 17 February 2022): No safety updates.
Safety Update (EMA 20 January 2022): The product information will be updated to add transverse myelitis (inflammation in the spinal cord) as a side effect. Information on the known side effect of thrombosis with thrombocytopenia syndrome (TTS; blood clots with low blood platelets) will be updated in the product information.
Safety Update (EMA 09 December 2021): Cutaneous small vessel vasculitis (inflammation of blood vessels in the skin) was recommended by PRAC to be added as a side effect to the product information of COVID-19 Vaccine Janssen.
Safety Update (EMA 11 November 2021): There are no updates to the product information. There is currently insufficient evidence of a possible link between COVID-19 Vaccine Janssen and either multisystem inflammatory syndrome (MIS) or menstrual disorders.
Safety Update (EMA 06 October 2021): Venous thromboembolism (VTE) (blood clotting in the veins) and immune thrombocytopenia (ITP), (and autoimmune condition with low blood blood platelet levels) will be added to the product information as side effects, together with warnings and advice.
Transverse myelitis (inflammation in parts of the spinal cord) was recommended by the EMA Pharmacovigilance Risk Assessment Committee (PRAC) to be added to the product information as a side effect of COVID-19 Vaccine Janssen.
Safety Update (EMA 08 September 2021): Recommended product information update to include swollen lymph nodes, unusual or decreased feeling in the skin, tinnitus, diarrhoea and vomiting as side effects.
Safety Update (EMA 11 August 2021): Guillain-Barré syndrome has been added to the product information as a very rare side effect. Recommended to update the product information to include immune thrombocytopenia, dizziness and tinnitus as side effects. 
Safety Update (EMA 14 July 2021): People who have previously had capillary leak syndrome must not receive COVID-19 Vaccine Janssen. Capillary leak syndrome may also occur as a side effect of COVID-19 Vaccine Janssen. The product information will be updated. COVID-19 Vaccine Janssen is effective in preventing COVID-19.
Safety Update (EMA 18 June 2021): There are no updates to the product information. COVID-19 Vaccine Janssen is effective in preventing COVID-19.
Safety Update (EMA 11 May 2021): Individuals diagnosed with thrombocytopenia within 3 weeks after vaccination with COVID-19 Vaccine Janssen should be actively investigated for signs of thrombosis; similarly, individuals who present with thrombosis within 3 weeks of vaccination should be evaluated for thrombocytopenia
Safety Update (EMA 27 April 2021): Unusual blood clots in combination with low blood platelet levels have been identified as a very rare side effect of COVID-19 Vaccine Janssen. Vaccinated persons should seek immediate medical attention if symptoms of blood clotting occur, to help avoid complications.

Nuvaxovid COVID-19 Vaccine (Novavax)

Safety Update (EMA 13 April 2022): No updates to the product information currently recommended.
Safety Update (EMA 17 March 2022): No safety updates. Not yet been used in the EU/EEA. [ECDC data from EU Member States as well as countries for the EAA (Norwary, Iceland, Liechtenstein)].
Safety Update (EMA 17 February 2022): No safety updates.
Safety Update (EMA 20 January 2022): No safety updates.

Vaxzevria COVID-19 Vaccine (AstraZeneca)

Safety Update (EMA 13 April 2022): No updates to the product information currently recommended.
Safety Update (EMA 17 March 2022): The EMA Pharmacovigilance Risk Assessment Committee (PRAC) is aware of results of an epidemiological study based on French national databases and posted on the EPI-PHARE website which suggest a slightly increased risk of myocardial infarction (heart attack) and pulmonary embolism (a blocked blood vessel in the lungs) following vaccination with Vaxzevria. In addition, a slightly increased risk of venous and/or arterial thromboses (blood clots) has been noted in other published studies. PRAC will collect and assess all available data, including data from the marketing authorisation holder, to determine whether the conditions may be caused by Vaxzevria.
Safety Update (EMA 17 February 2022): No safety updates.
Safety Update (EMA 20 January 2022): The product information will be updated to add transverse myelitis (inflammation in the spinal cord) as a side effect. Information on the known side effect of thrombosis with thrombocytopenia syndrome (TTS; blood clots with low blood platelets) will be updated in the product information.
Safety Update (EMA 09 December 2021): No new updates to the product information are currently recommended.
Safety Update (EMA 11 November 2021): Cerebrovascular venous and sinus thrombosis (CVST; blood clots in the brain) without thrombocytopenia (low blood platelet levels) has been observed very rarely following vaccination with Vaxzevria. CVST will be added to the product information as a side effect of Vaxzevria.
Safety Update (EMA 06 October 2021): Immune thrombocytopenia (an autoimmune condition with low blood platelet levels) will be added to the product information as a side effect, together with a warning and advice about thrombocytopenic disorders.
Safety Update (EMA 08 August 2021): The product information will be updated with Guillain-Barré syndrome (GBS) as a side effect of Vaxzevria. Pain in legs and arms or stomach and influenza-like symptoms have also been included in the product information as side effects. 
Safety Update (EMA 11 August 2021): No further updates to the product information are currently recommended.
Safety Update (EMA 14 July 2021): Vaccinated persons need to seek immediate medical attention if they develop weakness and paralysis in the extremities, possibly progressing to the chest and face, after vaccination with Vaxzevria, as these could be signs of Guillain-Barré syndrome. The product information will be updated. Vaxzevria is effective in preventing COVID-19.
Safety Update (EMA 18 June 2021): People who have previously had capillary leak syndrome must not receive Vaxzevria. Capillary leak syndrome may also occur as a side effect of Vaxzevria. The product information will be updated. Vaxzevria is effective in preventing COVID-19.
Safety Update (EMA 21 May 2021): Individuals who previously had blood clots with low blood platelets (thrombosis with thrombocytopenia syndrome, TTS) after Vaxzevria must not be given a second dose of Vaxzevria. Individuals with low blood platelets within 3 weeks after vaccination with Vaxzevria should be actively investigated for signs of blood clots; similarly, individuals who present with blood clots within 3 weeks of vaccination should be evaluated for low blood platelets. Patients who have blood clots with low blood platelets after vaccination require specialist medical care. Hypersensitivity reactions presenting as hives or rapid swelling under the skin in areas such as the face, lips, mouth and throat are newly identified side effects of Vaxzevria.
Safety Update (EMA 11 May 2021): Individuals diagnosed with thrombocytopenia within 3 weeks after vaccination with Vaxzevria should be actively investigated for signs of thrombosis; similarly, individuals who present with thrombosis within 3 weeks of vaccination should be evaluated for thrombocytopenia.
Safety Update (EMA 14 April 2021): Very rare, potentially serious, events of unusual blood clots in combination with low blood platelet levels have been confirmed as a new side effect of Vaxzevria.
Safety Update (EMA 29 March 2021): Severe allergic reaction will be included in the product information as a known side effect. A warning on very rare specific blood clot events has been included in the product information, while further investigations into a possible causal relationship with the vaccine are ongoing. Vaccinated persons should seek immediate medical attention if symptoms of blood clotting and/or bleeding occur.
 

Prescribing Information

 

Class Effects for mRNA and rDNA Vaccines

Class information is based on the four vaccines currently being used in Ireland.
In order to improve traceability of biological medicinals, clearly record the name and the batch number of the administered product.
 
CI: Hypersensitivity to any member of the class, vaccine component, trace substances after manufacture or following previous admin of a similar vaccine. Use of live viruses with immunosuppression (chemo- or radiotherapy, organ or bone marrow transplantation and/or currently on immunosuppressives including corticosteroids); impaired cell-mediated immunity (HIV infection, Severe Combined Immunodeficiency Syndrome, Di George Syndrome or congenital/hereditary immunodeficiency; severe humoral or cellular, primary or acquired immunodeficiency).
 
Interaction(s): Effect of Other Drugs on COVID-19 mRNA or rDNA Vaccines: No interaction studies performed.
 
SP: Hypersensitivity and anaphylaxis. Appropriate medical treatment and supervision to be available in case of anaphylactic reaction. Close observation for minimum 15 minutes after vaccination. 
Anxiety-related reactions e.g. vasovagal reactions (syncope), hyperventilation or stress-related reactions (dizziness, palpitations, increased heart rate, altered blood pressure, tingling sensations, sweating) may occur in association with the vaccination process itself. Usually temporary and resolve on their own. Advise vaccinees to bring symptoms to attention of vaccination provided to evaluate. Ensure precautions to avoid injury from fainting.
Concurrent illness, postpone (acute severe febrile illness, acute infection); do not delay (minor infection, low-grade fever). 
Thrombocytopenia, any coagulation disorder, individuals receiving anticoagulants, weigh risk/benefit of using IM route (bleeding or bruising may occur following IM admin). Vaccines may not protect 100% of recipients; reduced immunogenicity in immuno-compromised (immunosuppressive therapy, genetic causes). Duration of protection is still being determined by ongoing clinical trials.
 
Fertility, Pregnancy, Lactation: See mRNA and rDNA vaccines below.
 
Driving: Possible side-effects may affect ability. Do not drive if feeling unwell after vaccination.
 

COVID-19 mRNA Vaccines

  • ATC Code: J07BX03. 
  • Indication(s): Prevention, COVID-19 disease caused by SARS-CoV-2 virus from age 12 years (Comirnaty, Spikevax). 
  • Dose: Adult: Comirnaty 30mcg/dose, from age 12 years, after dilution (conc), as a 2-dose course (0.3mL each). Recommend to administer second dose 3 weeks after first dose. Comirnaty 30mcg/dose concentrate for dispersion for injection after dilution and Comirnaty 30mcg/dose dispersion for injection are considered interchangeable.

Spikevax, from age 12 years, as a 2-dose course (0.5mL each) 28 days apart.

Booster (both brands), from age 18 years, a booster (third) dose may be administered at least 6 months after second dose; severely immunocompromised, from age 12 years, a third dose may be admin at least 28 days after second dose.

Interchangeability with other COVID-19 vaccines to complete vaccination course, no data. Recommend course is completed with same vaccine as initial dose. 

Admin, IM injection, preferably deltoid muscle of upper arm. NOT for IV, SC or intradermal injection.

  • Elderly: Age 65 years and older, no dose adjustment. Booster dose safety and immunogenicity is based on adults aged 18 years and older.
  • Child: Age 12 years  and older, as for Adult. Under 12 years (Comirnaty 30mcg/dose, Spikevax), safety and efficacy not established. There is a (Comirnaty 10mcg/dose) paediatric formulation available for children aged 5 to less than 12 years. 
  • SP: Anaphylaxis with first dose, do not administer second dose. Individuals vaccinated may not be fully protected until 7 days (Comirnaty) or 14 days (Spikevax) after the second dose. 

Myocarditis and pericarditis (rare); primarily occurred with 14 days post-vaccination; more often after second vaccine and in younger men. Ensure vaccinees understand to seek immediate medical attention if they develop symptoms indicative of myocarditis or pericarditis e.g. (acute and persisting) chest pain, shortness of breath, palpitations (after vaccination). Erythema multiforme (red spots/patches on the skin) and unusual or decreased feeling in the skin. Anxiety-related reactions, concurrent illness, thrombocytopenia, coagulation disorders, see Class Effects above.

  • Pregnancy, Lactation: Pregnancy, a large amount of observational data from pregnant women vaccinated with m-RNA vaccines during second/third trimester have not shown an increased adverse pregnancy outcomes; pregnancy outcomes after vaccination during first trimester, limited data; no increased risk for miscarriage seen. Animal studies do not indicate direct or indirect harmful effects regarding pregnancy, embryo/foetal development, parturition or post-natal development. m-RNA vaccines can be used during pregnancy. Breast-feeding, no effects on breastfed newborn/infant are anticipated (systemic exposure of breastfeeding woman to m-RNA vaccines is negligible). Observational data from breastfeeding women after vaccination have not shown a risk for adverse effects in breastfed newborns/infants. m-RNA vaccines can be used during breastfeeding. Fertility, animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity.
  • ADR: Summary, most frequent, both brands, injection site pain, fatigue, headache, myalgia, chills, arthralgia, pyrexia, injection site swelling. Adverse reactions were usually mild or moderate in intensity and resolved within a few days after vaccination. A slightly lower frequency of reactogenicity events was associated with greater age. 
  • Comirnaty, safety profile in adolescents aged 12-15 years was similar to age 16 years and older; most frequent, fatigue, headache, myalgia, chills, arthralgias, pyrexia.
  • Spikevax, most frequent, nausea and vomiting, axillary swelling and/or tenderness, fever, injection site redness. Overall, higher incidence of some adverse reactions in younger age groups e.g. axillary swelling or tenderness, fatigue, headache, myalgia, arthralgia, chills, nausea and/or vomiting and fever was higher in ages 18 to under 65 years than in age 65 years and older. Local and systemic reactions were more frequently reported after Dose 2 than after Dose 1.
Comirnaty COVID-19 Vaccine (Pfizer/BioNTech)          
Concentrate for dispersion for injection, tozinameran 30mcg/0.3mL dose (DOVID-19 mRNA vaccine embedded in lipid nanoparticles). Tozinameran is a single-stranded mRNA (in vitro transcription) encoding SARS-CoV-2 viral spike (S) protein. White (off-white) frozen dispersion (concentrate) for dilution. 30mcg/dsoe vial has purple flip cap.
Excipient(s): Essentially sodium- and potassium-free. 
Store: Unopened vial, frozen: Nine months frozen at -90 to -60 deg C. Original pack (light). Can be stored and transported at -25 to -15 deg C for single 2-week period then can be returned to -90 to -60 deg C.
Unopened vial, thawed: One month at 2-8 degrees C. Within this 1-month, up to 12 hours may be used for transportation. Before using, up to 2 hours at temperatures of up to 30 deg C. Do not refreeze thawed vial. Thawed vial can be handled in room light conditions.
[Information up-to-date (EMA): March 2022]
 
▼ Spikevax COVID-19 Vaccine (formerly Moderna COVID-19 Vaccine) (Moderna)
Dispersion for injection, COVID-19 mRNA 100mcg/0.5mL dose embedded in lipid nanoparticles. Single-stranded mRNA (in vitro transcription) encoding SARS-CoV-2 viral spike (S) protein. White (off-white) dispersion. 
Excipient(s): Essentially sodium-free. 
Store: Freeze at -25 to -15 deg C. Original pack (light). Do not store on dry ice or below -50 deg C. Thawed vaccine, up to 30 days at 2-8 degrees C; do not refreeze. Removed from refrigerator, up to 12 hours at 8-25 deg C.
[Information up-to-date (EMA): March 2022]
 

COVID-19 rDNA Vaccines

  • ATC Code: J07BX03. 
  • Indication(s): Prevention, COVID-19 disease caused by SARS-CoV-2 virus from age 18 years. 
  • Dose: Adult: From age 18 years: As a single dose (0.5mL) (Janssen). As a 2-dose course (0.5mL each), between 4 and 12 weeks (28-84 days) apart (Vaxzevria) OR 3 weeks after first dose (Nuvaxovid). Admin, IM injection ONLY, preferably deltoid muscle of upper arm. NOT for IV, SC or intradermal injection.
  • Elderly: No dose adjustment.
  • Child: Age 18 years and older, as for Adult. Under 18 years, safety and efficacy not established.
  • CI: Individuals who have experienced thrombosis with thrombocytopenia syndrome (TTS) following vaccination. Individuals who have previously experienced episodes of capillary leak syndrome (CLS) (Janssen, Vaxzevria).
  • SP: Individuals vaccinated may not be fully protected until 14 days after single dose vaccination (Janssen) OR 15 days (Vaxzevria) OR 7 days (Nuvaxovid) after the second dose. Duration of protection is still being determined by ongoing clinical trials.

Janssen, Vaxzevria: Thrombosis with thrombocytopenia syndrome (rare), some cases with bleeding, post-vaccination, including severe cases presenting as venous thrombosis at unusual sites e.g. cerebral venous sinus thrombosis, splanchnic vein thrombosis and arterial thrombosis, with thrombocytopenia (some cases fatal). Majority occurred within first 3 weeks post-vaccination, mostly in women (both brands) under age 60 years (Janssen). Thrombosis with thrombocytopenia requires specialised clinical management; consult guidance and/or consult specialists e.g. haematologists, coagulation specialists to diagnose and treat.

Janssen, Vaxzevria: Very rarely reported, Guillain-Barré syndrome (GBS) following vaccination. H/care professionals to be alert for GBS signs and symptoms; ensure correct diagnosis (or rule out other causes) and initiate adequate supportive care and treatment. Capillary leak syndrome (CLS) in first days post-vaccination; some cases fatal. CLS characterised by acute episodes of oedema (mainly limbs), hypotension, haemoconcentration, hypoalbuminaemia. Acute CLS episode following vaccination requires prompt recognition, treatment. Intensive supportive therapy usually needed. Do not vaccinate with known CLS history.

Anxiety-related reactions, concurrent illness, thrombocytopenia, coagulation disorders, see Notes below (class effects).

  • Pregnancy, Lactation: Pregnancy, limited experience. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryo/foetal development, parturition or post-natal development. Use in pregnancy should only be considered when the potential benefits outweigh any potential risks for the mother and foetus.
Breast-feeding, unknown if excreted in human milk.
Fertility, animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity
  • ADRs: Summary, most frequent, (all brands), injection site pain, headache, fatigue, myalgia, nausea. Reactogenicity was generally milder and reported less frequently in older adults (age 65 years and older). 

Additional adverse reactions: Janssen, pyrexia; most reactions occurred within 1-2 days, were mild to moderate and of short duration (1-2 days). Nuvaxovid, injection site tenderness, arthralgia, malaise, vomiting; usually mild to moderate, under 2 days (local events) or 1 day (systemic events). Vaxzevria, pyrexia, injection site tenderness, malaise, chills, arthralgia; mild to moderate and usually resolved within a few days; second dose, milder, less frequent.

▼ COVID-19 Vaccine Janssen (Janssen-Cilag/Johnson & Johnson)
Injection, COVID-19 rDNA 0.5mL (one dose). Recombinant DNA technology. Adenovirus type 26 encoding SARS-CoV-2 Spike (S) glycoprotein (Ad26.COV2-S). Colourless (slightly-yellow) clear (very-opalescent). 
Excipient(s): Essentially sodium-free; ethanol 2mg/0.5mL. 
Store, Transport: Freeze (-25 to -15 deg). Can be refrigerated (2-8 deg C) for single period of up to 3 months. Do not re-freeze. Vials in outer carton (light). In-Use (not for storage or transport): Unopened, 9-25 deg C; max. 12  hours. 
[Information up-to-date (EMA): March 2022]
 
▼ Nuvaxovid COVID-19 Vaccine (Novavax)
Dispersion for injection, COVID-19 rDNA 0.5mL (one dose). SARS-CoV-2 spike protein adjuvanted with Matrix-M (Fraction A and C of Quillaja saponaria Molina extract). Recombinant DNA technology using aculovirus expression system in insect cell line (Sf9 cells of  Spodoptera frugiperda species). Colourless (slightly yellow) clear (mildly opalescent). 
Excipient(s): Essentially sodium- and potassium-free.
Store, Transport: Refrigerate (2-8 deg C). Do not freeze. Outer container (light). In-Use (not for storage or transport): Unopened, under 25 deg C (max. 12 hours).
[Information up-to-date (EMA): March 2022]
 
▼ Vaxzevria COVID-19 Vaccine (AstraZeneca)
Injection, COVID-19 rDNA 0.5mL (one dose). Recombinant DNA technology. Chimpanzee Adenovirus encoding SARS-CoV-2 Spike (S) glycoprotein (ChAdOx1-S). Colourless (slightly-brown) clear (slightly-opaque). 
Excipient(s): Essentially sodium-free; ethanol 2mg/0.5mL. 
Store: Refrigerate (2-8 deg C). Do not freeze. Vials in outer carton (light). 
[Information up-to-date (EMA): March 2022]
 
Page updated: 14 April 2022.